Clinical trial · Interventional
Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study
NCT05008471CI-TRIAL-00053339unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will present an advanced equipment of tumor nutrition diagnosis and assesment for nasopharyngeal cancer(NPC) radiotherapy patients in nutritional risk screening, evaluation, diagnosis and directing nutritional intervention, aiming to explore the advantages of the whole nutritional management in acute radiation reaction rate, completion rate of radiotherapy, nutritional status, and quality of life for NPC patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Nutrition Disorders | — | UNRESOLVED | — |
| Radiation Therapy Induced Change | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Formula nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The recommended target energy for NPC radiotherapy patients is 25-30kcal/(kg·d), in addition，the intervention group begins with an additional 50% daily energy increase during the peri-radiotherapy.
- interventionNames
- Dietary Supplement: Formula nutrition
- type
- NO_INTERVENTION
- label
- Conventional group
- description
- Unlike the intervention group,conventional group should be treated according to the consensus of experts on standardized nutrition management.
Primary outcomes (1)
- measure
- Incidence of acute radiation reactions
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with nasopharyngeal carcinoma confirmed by histopathology * Newly diagnosed patients without distant metastasis * Age \>18 * KPS ≥ 70 * Nasopharyngeal radiotherapy alone or concurrent chemoradiotherapy was planned to be received, andIMRT was used for radiotherapy * The patient's blood counts，the lung, liver and renal functions were tolerant to radiotherapy/chemoradiotherapy（ WBC ≥ 4.0\*109/L, NE ≥ 2.0\*109/L, PLT 100\*109/L and Hb≥ 10g/L. AST and ALT ≤ 2.5 \*the upper limit（UL） ,TBIL≤1.2\*the UL, CRE≤1.2\* the UL, and ALP≤5\* the UL）. And the ECG should be normal * Good nutritional status,BMI:18\~23Kg/ m2, PG-SGA ≤1,NRS 2002\<3score * No other previous neoplastic diseases, except for cured cervical carcinoma in situ skin basal carcinoma * No serious gastrointestinal diseases (moderate and severe duodenal and gastric ulcer, ulcerative colitis, Crohn's disease, etc.) * No AIDS and no diabetes * Clear mind, no communication barriers, able to answer questions * Voluntarily participate and sign the informed consent in person. Exclusion Criteria: * Patients with gastrointestinal dysfunction, intestinal obstruction, pyloric obstruction, Acute gastrointestinal bleeding * Patients who are allergic to nutritional therapy or have severe allergic constitution * Uncontrolled systemic diseases, such as severe liver disease (such as cirrhosis), kidney disease, respiratory diseases and so on. * Women who are pregnant or breastfeeding or no contraception and women with positive pregnancy test before receiving treatment * Special dietary requirements: such as no having a certain food or a vegetarian.
References
Publications (0)
Data not yet available
No reference posted for this study.